| CTRI Number |
CTRI/2023/03/050993 [Registered on: 23/03/2023] Trial Registered Prospectively |
| Last Modified On: |
22/03/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
THE EFFECT OF ANTISEPTIC NASAL SPRAY AFTER NOSE SURGERY |
|
Scientific Title of Study
|
THE EFFECT OF POVIDONE IODINE NASAL SPRAY ON THE HEALING PROCESS AFTER ENDOSCOPIC NASAL SINUS SURGERY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR YAZHINI V B |
| Designation |
POST GRADUATE ,DEPARTMENT OF ENT ,KIMS ,HUBLI |
| Affiliation |
KARNATAKA INSTITUTE OF MEDICAL SCIENCES, HUBLI. |
| Address |
DEPARTMENT OF ENT,KIMS,VIDHYA NAGAR ,HUBLI ,580029
DEPARTMENT OF ENT,KIMS,VIDHYA NAGAR,HUBLI
Dharwad
KARNATAKA
580029
India |
| Phone |
8220370376 |
| Fax |
|
| Email |
yazh.vb@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR VIKRAM K BHAT |
| Designation |
THE PROFESSOR AND UNIT CHIEF ,DEPARTMENT OF ENT ,KIMS,HUBLI |
| Affiliation |
KARNATAKA INSTITUTE OF MEDICAL SCIENCES,HUBLI,DHARWAD,KARNATAKA |
| Address |
DEPARTMENT OF ENT,
KARNATAKA INSTITUTE OF MEDICAL SCIENCES,HUBLI,DHARWAD,580029,
KARNATAKA.
DEPARTMENT OF ENT,
KARNATAKA INSTITUTE OF MEDICAL SCIENCES,HUBLI,DHARWAD,580029,
KARNATAKA.
Dharwad
KARNATAKA
580029
India |
| Phone |
8792847022 |
| Fax |
|
| Email |
Vikram.ent@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR VIKRAM K BHAT |
| Designation |
THE PROFESSOR AND UNIT CHIEF, DEPARTMENT OF ENT,KIMS,HUBLI |
| Affiliation |
KARNATAKA INSTITUTE OF MEDICAL SCIENCES,HUBLI |
| Address |
DEPARTMENT OF ENT,KARNATAKA INSTITUTE OF MEDICAL SCIENCES,
HUBLI,DHARWAD,580029,KARNATAKA
DEPARTMENT OF ENT,
KARNATAKA INSTITUTE OF MEDICAL SCIENCES ,HUBLI,DHARWAD,580029 KARNATAKA
Dharwad
KARNATAKA
580029
India |
| Phone |
8792847022 |
| Fax |
|
| Email |
Vikram.ent@gmail.com |
|
|
Source of Monetary or Material Support
|
| KARNATAKA INSTITUTE OF MEDICAL SCIENCES,HUBLI |
|
|
Primary Sponsor
|
| Name |
KARNATAKA INSTITUTE OF MEDICAL SCIENCES |
| Address |
KARNATAKA INSTITUTE OF MEDICAL SCIENCES,HUBLI |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR YAZHINI V B |
KARNATAKA INSTITUTE OF MEDICAL SCIENCES. |
DEPARTMENT OF ENT,
301 WARD,
THIRD FLOOR,
KARNATAKA INSTITUTE OF MEDICAL SCIENCES,VIDHYA NAGAR,HUBLI
Dharwad
KARNATAKA |
8220370376
yazh.vb@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE,KIMS,HUBLI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J329||Chronic sinusitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
POVIDONE IODINE NASAL SPRAY |
THE EFFECT OF 0.1% POVIDONE IODINE NASAL SPRAY IMMEDIATELY AFTER THE NASAL PACK REMOVAL FOR THE PERIOD OF 1 WEEK AS COMPARED TO SALINE NASAL SPRAY ON THE HEALING PROCESS AFTER ENDOSCOPIC NASAL SURGERY |
| Comparator Agent |
SALINE NASAL SPRAY |
THE EFFECT OF SALINE NASAL SPRAY IMMEDIATELY AFTER THE NASAL PACK REMOVAL FOR A PERIOD OF 1 WEEK COMPARED TO 0.1% POVIDONE IODINE NASAL SPRAY ON THE HEALING PROCESS AFTER ENDOSCOPIC SINUS SURGERY |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
20.00 Year(s) |
| Gender |
Both |
| Details |
1)ADULT PATIENTS WHO HAVE UNDERGONE ENDOSCOPIC SINUS SURGERY FOR CHRONIC RHINOSINUSITIS WITH OR WITH OUT POLYP ,WITH OR WITHOUT SEPTOPLASTY,TURBINECTOMY OR CONCHOTOMY,WITH OR WITHOUT INTERNAL SPLINT 2) REVISION SURGERIES OF THE SAME |
|
| ExclusionCriteria |
| Details |
1) PATIENTS WHO HAVE UNDERGONE RHINOPLASTY OR MEDIAL MAXILLECTOMY OR DENKER PROCEDURE OR ONLY SEPTOPLASTY 2)LOCAL NASAL DISEASE LIKE RHINOSCLEROMA OR ATROPHIC RHINITIS 3)HIV AND HBsAG POSTIVE PATIENT 4)DIABETIC PATIENTS 5) SINONASAL MUCORMYCOSIS |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1) TIME DURATION REQUIRED FOR NASAL HEALING AFTER SURGERY BASED ON NASAL ENDOSCOPY AND SNOT 22 SCORE |
1st NASAL SWAB TAKEN IMMEDIATELY AFTER THE PACK REMOVAL AND SENT FOR NASAL SWAB CULTURE AND LOOK FOR ANY GROWTH ( PATIENTS WIL USING EITHER POVIDONE IODINE NASAL SPRAY OR SALINE NASAL SPRAY) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1) CHANGE IN PATTERNS OR DISAPPEARANCE OF NASAL FLORA AFTER THE USE OF POVIDONE IODINE NASAL SPRAY.2) COMPLICATIONS OF SURGERIES IN THE 2GROUPS |
2nd NASAL SWAB TAKEN AFTER 1WEEK OF USAGE OF EITHER POVIDONE IODINE NASAL SPRAY OR SALINE NASAL SPRAY AND SENT FOR NASAL SWAB CULTURE AND LOOK FOR ANY GROWTH |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
23/03/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
WOUND HEALING AFTER INTRA NASAL SURGERIES LIKE ENDOSCOPIC SINUS SURGERY IS AFFECTED BY THE BACTERIAL LOAD INSIDE THE NOSE AFTER THE SURGERY. REDUCING THIS LOAD AFTER NASAL PACK REMOVAL WITH POVIDONE IODINE NASAL SPRAY,COULD ENHANCE AND HASTEN THE HEALING PROCESS HENCE THE NEED FOR THE STUDY. |